Cleared Traditional

K143518 - Valeo Spacer System and Valeo II Interb...

K143518 is the FDA 510(k) clearance for Valeo Spacer System and Valeo II Interb... by Amedica Corp.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K143518 · Amedica Corp. · Orthopedic device
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Oct 2015
Decision
294d
Days
Class 2
Risk

K143518 is an FDA 510(k) clearance for the Valeo Spacer System and Valeo II Interbody Fusion Device System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Amedica Corp. (Slat Lake City, US). The FDA issued a Cleared decision on October 2, 2015 after a review of 294 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Amedica Corp. devices

Submission Details

510(k) Number K143518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2014
Decision Date October 02, 2015
Days to Decision 294 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 122d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 604
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K143518.
PIVOX(tm) Oblique Lateral Spinal System
K152277 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
Px HA PEEK IBF System
K151785 · Innovasis, Inc. · Oct 2015
CONCORDE Bullet Spinal System
K151352 · Medos International SARL · Oct 2015
LOSPA IS Spinal System
K151408 · Corentec Co., Ltd. · Oct 2015
NuVasive CoRoent Lumbar System
K151472 · Nu Vasive, Incorporated · Sep 2015
Cascadia Interbody System
K150481 · K2m, Inc. · Aug 2015